At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 512 enrolled
Drug / intervention
Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg +3 moredrug
Likely dose
Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg, Fluticasone Propionate 250mcg / salmeterol 50mcg, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 512 participants across 51 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesGermany, Italy, South Africa, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionJan 2012
Study CompletionJan 2012
TodayJul 2026
First PostedMar 25, 2011
Enrollment StartMar 18, 2011
Primary CompletionJan 1, 2012
Study CompletionJan 24, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.3 years ago
Interventions
Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcgdrug
inhalation powder
Fluticasone Propionate 250mcg / salmeterol 50mcgdrug
inhalation powder
Double-dummy placebodrug
inhalation powder
Salbutamol as neededdrug
inhalation powder